Clinical trial · Observational
Impact of Fusobacterium Nucleatum on Response to Anti-EGFR Therapy in Metastatic Colorectal Cancer
Association Between Intratumoral Fusobacterium Nucleatum Burden and Therapeutic Resistance to Anti-EGFR Monoclonal Antibodies in Metastatic Colorectal Cancer: An Integrated Analysis of Clinical and Molecular Data
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This retrospective observational cohort study investigates the association between the intratumoral burden of the bacterium Fusobacterium nucleatum (Fn) and the efficacy of anti-EGFR targeted therapies (cetuximab or panitumumab) in patients with RAS wild-type metastatic colorectal cancer (mCRC). Bacterial quantification will be performed using droplet digital polymerase chain reaction (ddPCR) on formalin-fixed, paraffin-embedded (FFPE) tissue samples, comprising an estimated cohort of 500 patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1 - High Fn
- description
- Patients with intratumoral Fusobacterium nucleatum burden above the median.
- label
- Cohort 2 - Low/Negative Fn
- description
- Patients with intratumoral Fusobacterium nucleatum burden less than or equal to the median, or with undetectable infection
Primary outcomes (3)
- measure
- Objective Response Rate (ORR)
- timeFrame
- From the date of first anti-EGFR administration until disease progression, assessed up to 186 months
- description
- Proportion of patients who achieved complete or partial response as assessed according to standardized RECIST 1.1 criteria.
- measure
- Overall Survival (OS)
- timeFrame
- From the date of initial anti-EGFR therapy administration to the date of death from any cause, with a maximum follow-up assessment of up to 186 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of metastatic (Stage IV) adenocarcinoma of the colon or rectum. * Received at least one cycle of anti-EGFR therapy (cetuximab or panitumumab), either as monotherapy or in combination regimens, regardless of the line of therapy. * Anti-EGFR therapy administered between January 2016 and December 2022. * Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (from primary tumor or metastatic site) stored in the institutional biobank, with adequate quality for molecular analysis Exclusion Criteria: * Primary tumor originating in sites other than the colon or rectum. * Presence of activating mutations in KRAS or NRAS genes. * Presence of BRAF gene mutation (except for patients who received anti-EGFR therapy combined with BRAF inhibitors, according to standard clinical practice for this subgroup). * Tumor histology other than adenocarcinoma. * Insufficient clinical or follow-up data in medical records for the evaluation of the study's primary endpoints
References
Publications (0)
Data not yet available